Spinal Cord InjuryPhase 2/3NCT01652040
Resistance Training and Testosterone After Spinal Cord Injury
A Phase 2/3 study testing Resistance Training and Testosterone Patches and Testosterone Patches in people with Spinal Cord Injury, run by VA Office of Research and Development at 1 site in United States.
Trial summary
The goal of this proposal is to investigate the efficacy of a complimentary approach of evoked resistance training and testosterone replacement therapy on the changes in body composition and metabolic profile after SCI. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men only
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- Resistance Training and Testosterone Patches and Testosterone Patches
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jul 2012to 30 Dec 2017
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Male with Spinal Cord Injury
- Between 18-50 years old
- BMI < 30 Kg/m2
- Traumatic motor complete C5-L2 level of injury
- American Spinal Injury Classification (A and B; i.e. motor deficit below the level of injury)
Who cannot join
- Cardiovascular disease
- Uncontrolled type II DM and those on insulin
- Pressures sores stage 2 or greater
- Supra-physiological T level
- Hematocrit above 50%
- Urinary tract infection or symptoms
Trial locations and contacts
1 site in 1 country.
United States1 site
Hunter Holmes McGuire VA Medical Center, Richmond, VA
Richmond, Virginia, 23249
About this study
Official title: Effects of Evoked Resistance Training and Testosterone After Spinal Cord Injury
The goal of this proposal is to investigate the efficacy of a complimentary approach of evoked resistance training and testosterone replacement therapy on the changes in body composition and metabolic profile after SCI. The proposed method could become a recommended and simple intervention especially for individuals with limited access and poor tolerance to exercise. The rationale is based on the evidence that individuals with SCI experience decline in anabolic hormones which may be responsible for the deterioration in body composition and metabolic profiles and leads to increase obesity, type 2 diabetes mellitus, dyslipidemia and subsequently cardiovascular disease. The designed study will provide explanation to the adaptations in the energy source of the muscle cells in response to training.
Read the detailed description
Individuals with spinal cord injury (SCI) are at a lifelong risk of increasing obesity and several chronic metabolic disorders such as glucose intolerance, insulin resistance and dyslipidemia secondary to deterioration in body composition. Within few weeks of injury, there are significant decrease in whole body fat-free mass (FFM), particularly lower extremity skeletal muscle mass and subsequent increase in fat mass (FM). Resistance training (RT) is an important type of exercise that has been shown to induce positive physiological adaptations such as increasing lean mass and reducing metabolic disorders in other clinical populations.
In a pilot work, the investigators provided evidence that evoked RT using surface neuromuscular electrical stimulation (NMES) for knee extensor muscle group resulted in significant increase skeletal muscle cross-sectional area (CSA), reduction in % leg FM and a trend towards decrease in visceral adipose tissue (VAT) CSA. The favorable adaptations in body composition were associated with decrease in plasma insulin area under the curve and plasma triglycerides. The investigators attributed the adaptations in body composition and metabolic profile to an associated increase in plasma insulin-like growth factor (IGF-1). The investigators concluded that twelve weeks of evoked RT targeted towards evoking skeletal muscle hypertrophy could result in significant body composition and metabolic adaptations in individuals with SCI.
It is unclear if a longer RT program greater than 12 weeks would provide additional benefits to Veterans with SCI. It is also unknown whether enhancing the decline anabolic homeostasis by providing testosterone (T) replacement therapy (TRT) would reverse body composition and metabolic profile changes in Veterans with SCI. The major research goal of this proposal is to investigate the effects of 16 weeks of evoked RT+TRT vs. TRT on body composition (muscle CSA, VAT, %FM) and the metabolic profiles (glucose and lipid metabolism) in individuals with motor complete SCI. To address this goal, surface NMES accompanied with ankle weights will be conducted twice weekly to exercise the knee extensor skeletal muscle groups from sitting position. After 4 weeks of delayed entry approach, participants (n =24) will be randomly assigned into RT+TRT (n =12) or TRT (n =12) groups. The TRT will be provided via transdermal T patches that will be alternated on both shoulders over the course of the study. The investigators also propose to study the effects of detraining on body composition and metabolic profiles.
The research plan includes three specific aims
Specific aim 1 will demonstrate the effects of NMES RT and/or Testosterone patches (Tp) on the CSA of thighs and legs skeletal muscle groups, percentage FFM, and the CSA of VAT, intramuscular fat and percentage FM after 16 weeks of training+Tp and 16 weeks of detraining.
Specific aim 2 will determine the changes in metabolic milieu (resting energy expenditure, glucose homeostasis, lipid profile, free fatty acids, serum total and free testosterone and IGF-1), and cytokines (c-reactive protein, tumor necrosis factor alpha and IL-6 as inflammatory biomarkers) after 16 weeks of training+Tp and detraining.
Specific aim 3 will determine if 16 weeks of evoked RT and Tp will increase GLUT-4 concentration, muscle IGF-1 and peroxisome-proliferator-activated receptor-gamma co-activator 1 (PGC-1) expressions, altered fiber type distribution and enhance the mitochondrial enzymatic activities (electron transport chain) compared to Tp only.
- Conditions
- Spinal Cord Injury
- Being tested
- Resistance Training and Testosterone Patches, Testosterone Patches
- Keywords
- Spinal Cord Injury, Rehabilitation, Electrical Stimulation, Testosterone, Body Composition, Lipid and Glucose profile, Ectopic Adiposity
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance Training and Testosterone PatchesDevice
We are going to activate the knee extensor muscle group to lift ankle weights over 16 weeks and we are going to provide Tp to improve anabolic profile.
Testosterone PatchesDrug
The investigators will provide Tp patches for 16 weeks for patients with Spinal Cord Injury.
| Study group | Role | What they receive |
|---|---|---|
| RT+Tp | Experimental | Resistance training using electrical stimulation and ankle weights and Testosterone patches Receives: Device: Resistance Training and Testosterone Patches |
| Tp | Experimental | Applying Testosterone patches Receives: Drug: Testosterone Patches |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Composition
Changes in body composition fat mass
Measured: 16 weeks
Secondary outcomes (1)
Metabolic Profile
Basal Metabolic Rate
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2012 (estimated)
- Study start2 Jul 2012
- Primary completion30 Dec 2017
- Study completion30 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- Virginia Commonwealth University
- Responsible party
- Sponsor
- Investigators
- Ashraf Gorgey, PhD PT, Principal investigator, Hunter Holmes McGuire VA Medical Center, Richmond, VA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01652040
- Sponsor's protocol ID
- B7867-W
- Status last verified
- May 2018
- First submitted
- 13 Jul 2012
- Last updated
- 3 May 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Gorgey AS, Khalil RE, Gill R, O'Brien LC, Lavis T, Castillo T, Cifu DX, Savas J, Khan R, Cardozo C, Lesnefsky EJ, Gater DR, Adler RA. Effects of Testosterone and Evoked Resistance Exercise after Spinal Cord Injury (TEREX-SCI): study protocol for a randomised controlled trial. BMJ Open. 2017 Apr 4;7(4):e014125. doi: 10.1136/bmjopen-2016-014125.
PubMed 28377392Gorgey AS, Moore PD, Wade RC, Gill RS, Lavis T, Adler RA. Disruption in bone marrow fat may attenuate testosterone action on muscle size after spinal cord injury: a case report. Eur J Phys Rehabil Med. 2017 Aug;53(4):625-629. doi: 10.23736/S1973-9087.17.04452-5. Epub 2017 Mar 13.
PubMed 28290190Wade RC, Gorgey AS. Anthropometric prediction of skeletal muscle cross-sectional area in persons with spinal cord injury. J Appl Physiol (1985). 2017 May 1;122(5):1255-1261. doi: 10.1152/japplphysiol.01042.2016. Epub 2017 Mar 2.
PubMed 28255089O'Brien LC, Wade RC, Segal L, Chen Q, Savas J, Lesnefsky EJ, Gorgey AS. Mitochondrial mass and activity as a function of body composition in individuals with spinal cord injury. Physiol Rep. 2017 Feb;5(3):e13080. doi: 10.14814/phy2.13080.
PubMed 28193782Moore PD, Gorgey AS, Wade RC, Khalil RE, Lavis TD, Khan R, Adler RA. Neuromuscular electrical stimulation and testosterone did not influence heterotopic ossification size after spinal cord injury: A case series. World J Clin Cases. 2016 Jul 16;4(7):172-6. doi: 10.12998/wjcc.v4.i7.172.
PubMed 27458592Gorgey AS, Caudill C, Khalil RE. Effects of once weekly NMES training on knee extensors fatigue and body composition in a person with spinal cord injury. J Spinal Cord Med. 2016;39(1):99-102. doi: 10.1179/2045772314Y.0000000293. Epub 2015 Jan 23.
PubMed 25615403Gorgey AS, Mather KJ, Cupp HR, Gater DR. Effects of resistance training on adiposity and metabolism after spinal cord injury. Med Sci Sports Exerc. 2012 Jan;44(1):165-74. doi: 10.1249/MSS.0b013e31822672aa.
PubMed 21659900Gorgey AS, Shepherd C. Skeletal muscle hypertrophy and decreased intramuscular fat after unilateral resistance training in spinal cord injury: case report. J Spinal Cord Med. 2010;33(1):90-5. doi: 10.1080/10790268.2010.11689681.
PubMed 20397451Khalil RE, Gorgey AS, Janisko M, Dolbow DR, Moore JR, Gater DR. The role of nutrition in health status after spinal cord injury. Aging Dis. 2013 Feb;4(1):14-22. Epub 2012 Nov 30.
PubMed 23423356Gorgey AS, Dolbow DR, Cifu DX, Gater DR. Neuromuscular electrical stimulation attenuates thigh skeletal muscles atrophy but not trunk muscles after spinal cord injury. J Electromyogr Kinesiol. 2013 Aug;23(4):977-84. doi: 10.1016/j.jelekin.2013.04.007. Epub 2013 May 15.
PubMed 23683374Nightingale TE, Moore P, Harman J, Khalil R, Gill RS, Castillo T, Adler RA, Gorgey AS. Body composition changes with testosterone replacement therapy following spinal cord injury and aging: A mini review. J Spinal Cord Med. 2018 Nov;41(6):624-636. doi: 10.1080/10790268.2017.1357917. Epub 2017 Aug 3.
PubMed 28770686Gorgey AS, Lester RM, Wade RC, Khalil RE, Khan RK, Anderson ML, Castillo T. A feasibility pilot using telehealth videoconference monitoring of home-based NMES resistance training in persons with spinal cord injury. Spinal Cord Ser Cases. 2017 Jun 29;3:17039. doi: 10.1038/scsandc.2017.39. eCollection 2017.
PubMed 29021917Nightingale TE, Gorgey AS. Predicting Basal Metabolic Rate in Men with Motor Complete Spinal Cord Injury. Med Sci Sports Exerc. 2018 Jun;50(6):1305-1312. doi: 10.1249/MSS.0000000000001548.
PubMed 29315167Abilmona SM, Gorgey AS. Associations of the trunk skeletal musculature and dietary intake to biomarkers of cardiometabolic health after spinal cord injury. Clin Physiol Funct Imaging. 2018 Feb 6. doi: 10.1111/cpf.12505. Online ahead of print.
PubMed 29405604Rankin KC, O'Brien LC, Gorgey AS. Quantification of trunk and android lean mass using dual energy x-ray absorptiometry compared to magnetic resonance imaging after spinal cord injury. J Spinal Cord Med. 2019 Jul;42(4):508-516. doi: 10.1080/10790268.2018.1438879. Epub 2018 Feb 20.
PubMed 29461936
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Evoked Resistance Training and Testosterone After Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT01652040
- Acronym / sponsor ID
- B7867-W
- Conditions
- Spinal Cord Injury
- Keywords
- Spinal Cord Injury, Rehabilitation, Electrical Stimulation, Testosterone, Body Composition, Lipid and Glucose profile, Ectopic Adiposity
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- Virginia Commonwealth University
- Study start
- 2 Jul 2012 (actual)
- Primary completion
- 30 Dec 2017 (actual)
- Study completion
- 30 Dec 2017 (actual)
- First posted
- 27 Jul 2012 (estimated)
- Results
- Posted 3 May 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this proposal is to investigate the efficacy of a complimentary approach of evoked resistance training and testosterone replacement therapy on the changes in body composition and metabolic profile after SCI. The proposed method could become a recommended and simple intervention especially for individuals with limited access and poor tolerance to exercise. The rationale is based on the evidence that individuals with SCI experience decline in anabolic hormones which may be responsible for the deterioration in body composition and metabolic profiles and leads to increase obesity, type 2 diabetes mellitus, dyslipidemia and subsequently cardiovascular disease. The designed study will provide explanation to the adaptations in the energy source of the muscle cells in response to training.
Detailed description
Individuals with spinal cord injury (SCI) are at a lifelong risk of increasing obesity and several chronic metabolic disorders such as glucose intolerance, insulin resistance and dyslipidemia secondary to deterioration in body composition. Within few weeks of injury, there are significant decrease in whole body fat-free mass (FFM), particularly lower extremity skeletal muscle mass and subsequent increase in fat mass (FM). Resistance training (RT) is an important type of exercise that has been shown to induce positive physiological adaptations such as increasing lean mass and reducing metabolic disorders in other clinical populations.
In a pilot work, the investigators provided evidence that evoked RT using surface neuromuscular electrical stimulation (NMES) for knee extensor muscle group resulted in significant increase skeletal muscle cross-sectional area (CSA), reduction in % leg FM and a trend towards decrease in visceral adipose tissue (VAT) CSA. The favorable adaptations in body composition were associated with decrease in plasma insulin area under the curve and plasma triglycerides. The investigators attributed the adaptations in body composition and metabolic profile to an associated increase in plasma insulin-like growth factor (IGF-1). The investigators concluded that twelve weeks of evoked RT targeted towards evoking skeletal muscle hypertrophy could result in significant body composition and metabolic adaptations in individuals with SCI.
It is unclear if a longer RT program greater than 12 weeks would provide additional benefits to Veterans with SCI. It is also unknown whether enhancing the decline anabolic homeostasis by providing testosterone (T) replacement therapy (TRT) would reverse body composition and metabolic profile changes in Veterans with SCI. The major research goal of this proposal is to investigate the effects of 16 weeks of evoked RT+TRT vs. TRT on body composition (muscle CSA, VAT, %FM) and the metabolic profiles (glucose and lipid metabolism) in individuals with motor complete SCI. To address this goal, surface NMES accompanied with ankle weights will be conducted twice weekly to exercise the knee extensor skeletal muscle groups from sitting position. After 4 weeks of delayed entry approach, participants (n =24) will be randomly assigned into RT+TRT (n =12) or TRT (n =12) groups. The TRT will be provided via transdermal T patches that will be alternated on both shoulders over the course of the study. The investigators also propose to study the effects of detraining on body composition and metabolic profiles.
The research plan includes three specific aims
Specific aim 1 will demonstrate the effects of NMES RT and/or Testosterone patches (Tp) on the CSA of thighs and legs skeletal muscle groups, percentage FFM, and the CSA of VAT, intramuscular fat and percentage FM after 16 weeks of training+Tp and 16 weeks of detraining.
Specific aim 2 will determine the changes in metabolic milieu (resting energy expenditure, glucose homeostasis, lipid profile, free fatty acids, serum total and free testosterone and IGF-1), and cytokines (c-reactive protein, tumor necrosis factor alpha and IL-6 as inflammatory biomarkers) after 16 weeks of training+Tp and detraining.
Specific aim 3 will determine if 16 weeks of evoked RT and Tp will increase GLUT-4 concentration, muscle IGF-1 and peroxisome-proliferator-activated receptor-gamma co-activator 1 (PGC-1) expressions, altered fiber type distribution and enhance the mitochondrial enzymatic activities (electron transport chain) compared to Tp only.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RT+Tp | Experimental | Device: Resistance Training and Testosterone PatchesResistance training using electrical stimulation and ankle weights and Testosterone patches |
| Tp | Experimental | Drug: Testosterone PatchesApplying Testosterone patches |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male with Spinal Cord Injury
- Between 18-50 years old
- BMI < 30 Kg/m2
- Traumatic motor complete C5-L2 level of injury
- American Spinal Injury Classification (A and B; i.e. motor deficit below the level of injury)
Key exclusion criteria (6 listed)
- Cardiovascular disease
- Uncontrolled type II DM and those on insulin
- Pressures sores stage 2 or greater
- Supra-physiological T level
- Hematocrit above 50%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resistance Training and Testosterone PatchesWe are going to activate the knee extensor muscle group to lift ankle weights over 16 weeks and we are going to provide Tp to improve anabolic profile. | Device | RT+Tp |
| Testosterone PatchesThe investigators will provide Tp patches for 16 weeks for patients with Spinal Cord Injury. | Drug | Tp |
Primary outcome
Body Composition
Time frame: 16 weeks
Changes in body composition fat mass
1 secondary outcome
Metabolic Profile
Time frame: 16 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 28377392Gorgey AS, Khalil RE, Gill R, O'Brien LC, Lavis T, Castillo T, Cifu DX, Savas J, Khan R, Cardozo C, Lesnefsky EJ, Gater DR, Adler RA. Effects of Testosterone and Evoked Resistance Exercise after Spinal Cord Injury (TEREX-SCI): study protocol for a randomised controlled trial. BMJ Open. 2017 Apr 4;7(4):e014125. doi: 10.1136/bmjopen-2016-014125.
- Background: PubMed 28290190Gorgey AS, Moore PD, Wade RC, Gill RS, Lavis T, Adler RA. Disruption in bone marrow fat may attenuate testosterone action on muscle size after spinal cord injury: a case report. Eur J Phys Rehabil Med. 2017 Aug;53(4):625-629. doi: 10.23736/S1973-9087.17.04452-5. Epub 2017 Mar 13.
- Background: PubMed 28255089Wade RC, Gorgey AS. Anthropometric prediction of skeletal muscle cross-sectional area in persons with spinal cord injury. J Appl Physiol (1985). 2017 May 1;122(5):1255-1261. doi: 10.1152/japplphysiol.01042.2016. Epub 2017 Mar 2.
- Background: PubMed 28193782O'Brien LC, Wade RC, Segal L, Chen Q, Savas J, Lesnefsky EJ, Gorgey AS. Mitochondrial mass and activity as a function of body composition in individuals with spinal cord injury. Physiol Rep. 2017 Feb;5(3):e13080. doi: 10.14814/phy2.13080.
- Background: PubMed 27458592Moore PD, Gorgey AS, Wade RC, Khalil RE, Lavis TD, Khan R, Adler RA. Neuromuscular electrical stimulation and testosterone did not influence heterotopic ossification size after spinal cord injury: A case series. World J Clin Cases. 2016 Jul 16;4(7):172-6. doi: 10.12998/wjcc.v4.i7.172.
- Background: PubMed 25615403Gorgey AS, Caudill C, Khalil RE. Effects of once weekly NMES training on knee extensors fatigue and body composition in a person with spinal cord injury. J Spinal Cord Med. 2016;39(1):99-102. doi: 10.1179/2045772314Y.0000000293. Epub 2015 Jan 23.
- Background: PubMed 21659900Gorgey AS, Mather KJ, Cupp HR, Gater DR. Effects of resistance training on adiposity and metabolism after spinal cord injury. Med Sci Sports Exerc. 2012 Jan;44(1):165-74. doi: 10.1249/MSS.0b013e31822672aa.
- Background: PubMed 20397451Gorgey AS, Shepherd C. Skeletal muscle hypertrophy and decreased intramuscular fat after unilateral resistance training in spinal cord injury: case report. J Spinal Cord Med. 2010;33(1):90-5. doi: 10.1080/10790268.2010.11689681.
- Background: PubMed 23423356Khalil RE, Gorgey AS, Janisko M, Dolbow DR, Moore JR, Gater DR. The role of nutrition in health status after spinal cord injury. Aging Dis. 2013 Feb;4(1):14-22. Epub 2012 Nov 30.
- Background: PubMed 23683374Gorgey AS, Dolbow DR, Cifu DX, Gater DR. Neuromuscular electrical stimulation attenuates thigh skeletal muscles atrophy but not trunk muscles after spinal cord injury. J Electromyogr Kinesiol. 2013 Aug;23(4):977-84. doi: 10.1016/j.jelekin.2013.04.007. Epub 2013 May 15.
- Background: PubMed 28770686Nightingale TE, Moore P, Harman J, Khalil R, Gill RS, Castillo T, Adler RA, Gorgey AS. Body composition changes with testosterone replacement therapy following spinal cord injury and aging: A mini review. J Spinal Cord Med. 2018 Nov;41(6):624-636. doi: 10.1080/10790268.2017.1357917. Epub 2017 Aug 3.
- Background: PubMed 29021917Gorgey AS, Lester RM, Wade RC, Khalil RE, Khan RK, Anderson ML, Castillo T. A feasibility pilot using telehealth videoconference monitoring of home-based NMES resistance training in persons with spinal cord injury. Spinal Cord Ser Cases. 2017 Jun 29;3:17039. doi: 10.1038/scsandc.2017.39. eCollection 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Spinal Cord Injury
Recruiting
MyHand-SCI: An Active Hand Orthosis for Spinal Cord Injury
Spinal Cord Injuries, Tetraplegia
Recruiting
Clinical Outcome Assessment for AT & BCI
Spinal Cord Injury, ALS (Amyotrophic Lateral Sclerosis)
Recruiting
Transcutaneous Spinal Cord Stimulation Combined With 4-Aminopyridine and Intensive Rehabilitation in SCI
Spinal Cord Injuries
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
RecruitingPhase 3
A Trial Investigating the Efficacy and Safety of NVG-291 in Subjects With Chronic Spinal Cord Injury
Chronic Spinal Cord Injury
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ashraf Gorgey, PhD PT principal investigator
Hunter Holmes McGuire VA Medical Center, Richmond, VA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Resistance Training and Testosterone Patches and Testosterone Patches in people with Spinal Cord Injury, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 May 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Composition (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01652040, which also lists 25 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2018.